Selpercatinib, SEPADX, Selpercatinib 40mg Manufacturer: Laos Daxiong Pharmaceutical

Introduction: On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved selpercatinib, the first drug approved specifically for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) that is positive for rearranged within transfection (RET) fusion, and adults and children aged 12 years and older with advanced or metastatic medullary thyroid cancer that carries RET mutations and requires systemic treatment, as well as adults and children aged 12 years and older with advanced or metastatic thyroid cancer that is refractory to systemic treatment and radioactive iodine therapy (if applicable).

【Drug name】

Name: Serpatinib

Product Name: SEPADX

【Specification】

40 mg

【Indications】

SEPADX is a kinase inhibitor indicated for the treatment of:

• Adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)

• Adults and pediatric patients 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy

• Adults and pediatric patients 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioiodine (if radioiodine is appropriate)

【Recommended dosage】

• Patients are selected for SEPADX treatment based on the presence of RET gene fusions (NSCLC or thyroid) or specific RET gene mutations (MTC) • Recommended doses for adults and pediatric patients 12 years of age or older are based on weight:

oWeight less than 50 kg: 120 mg orally twice a day

o50 kg or more: 160 mg orally twice a day

• Reduce the dose of SEPADX in patients with severe hepatic impairment.

【side effect】

The most common side effects of SEPADX in adults are:

• Increased liver enzyme levels • Increased blood sugar levels

• Decreased white blood cell count • Decreased levels of protein (albumin) in the blood

• Low calcium levels in the blood • Dry mouth

• Diarrhea • Increased creatinine (kidney function test)

• High blood pressure • Fatigue

• Swelling of the arms, legs, hands, and feet (peripheral edema)

• Decreased platelet count

• Increased cholesterol levels • Skin rash

• Decreased salt (sodium) levels in the blood • Constipation

【Storage】

• Store SEPADX at room temperature between 59°F and 86°F (15°C and 30°C).

Keep SEPADX and all medicines out of the reach of children.